Overview

Intra-articular Adipose Tissue Injections for Osteoarthritis

Status:
Unknown status
Trial end date:
2020-12-01
Target enrollment:
0
Participant gender:
All
Summary
A new generation of "minimally manipulated" regenerative treatments are being offered at clinics across the country, but there is no strong efficacy data to support their use. The purpose of this study is to estimate the effect size of the treatment by comparing the efficacy of autologous fat to the current standard of care treatment, hyaluronic acid (HA). As a secondary aim, we will test for preliminary evidence of efficacy of autologous fat vs. HA and determine how these treatments effect the biochemical environment of the knee by comparing pre-injection and post-injection synovial fluid biomarker profiles.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Southern California
Treatments:
Hyaluronic Acid
Criteria
Inclusion Criteria:

1. Age 45 to 75, inclusive

2. Normal axial alignment

3. X-ray, Kellgren-Lawrence OA grade 2 - 3, inclusive

4. WOMAC-pain: Between 9 and 19, inclusive

5. Willingness to participate all scheduled follow-ups

6. Willingness to refrain from taking NSAIDs, level 2 analgesics, and opioids for the
course of the study

7. BMI < 40

Exclusion Criteria:

1. Pregnant or lactating

2. Intra-articular injection within 3 months of treatment

3. Inflammatory arthritis

4. Any disease or active drug use that significantly compromises coagulation

5. Significant damage and/or tears of the ACL or other supporting tissues

6. Prior knee surgery in the last 6 months in the knee that will be injected

7. Active tobacco use

8. Active alcohol or substance abuse within 6 months of study entry

9. Known hypersensitivity (allergy) to hyaluronan (sodium hyaluronate) preparations

10. Knee joint infections, skin diseases or infections in the area of the injection site

11. Diabetes

12. Active inhaler use

13. Any medical condition, which in the opinion of the clinical investigator, would
interfere with the treatment or outcome evaluation